Mobile Health Technology-Enabled AFib Management (mTECH Afib)

Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2

The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life.

Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Behavior
• Intervention / Treatment: Combination product: Corrie Virtual Atrial Fibrillation Management Program

• Study Type: Interventional
• Enrollment (Estimated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nino Isakadze; Phone Number: 410-955-5999; Email: nisakad1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Medical Center
      • Contact: Natalie Horstman; Phone Number: 443-839-0803; Email: nhorstm3@jh.edu
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Outpatient Center
      • Contact: Natalie Horstman; Phone Number: 443-839-0803; Email: nhorstm3@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 or older at time of consent
2. Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation
3. BMI (Body Mass Index) ≥ 27.0

Exclusion Criteria:

1. Permanent Afib (decision has been made not to attempt sinus rhythm)
2. Severe valvular disease
3. Moderate mitral valve stenosis
4. Prior cardiac surgery
5. Presence of implanted cardiac device
6. History of cardiac arrest
7. Left ventricular ejection fraction (LVEF) ≤ 35%
8. Life expectancy < 1 year
9. Non-English speaking
10. Treating clinician deems unsafe for exercise
11. Any other reason that makes patient unsuitable for study at the discretion of the PI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Experimental: Corrie Virtual Atrial Fibrillation Management Program; Multicomponent virtual atrial fibrillation management program	Combination product: Corrie Virtual Atrial Fibrillation Management Program; Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Freedom from documented atrial tachyarrhythmia	Freedom from documented atrial tachyarrhythmia (atrial fibrillation/atrial flutter/atrial tachycardia) episodes of ≥30 seconds between 91 and 365 days after catheter ablation, on or off antiarrhythmic drugs.	91 to 365 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT)	Quality of Life, measured by validated Atrial Fibrillation Effect on Quality of Life (AFEQT) score. Score ranges from 0 to 100 with higher scores signifying better quality of life	365 days
AFib burden (percentage of time)	Atrial fibrillation burden (expressed as a percentage of time in atrial fibrillation) between 91 days and 365 days after catheter ablation	91 to 365 days
Participants Freedom from atrial tachyarrhythmia off medication	Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between 91 days and 365 days after catheter ablation off medications.	91 to 365 days
Participants Freedom from atrial tachyarrhythmia on or off medications	Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between day 1 and day 365 after catheter ablation, on and off medications.	1 day to 365 days
Incidence of hospitalizations, emergency room visits, deaths	Safety (composite of hospitalizations, emergency room visits, deaths)	1 to 365 days

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Itamar-Medical, Israel; Apple Inc.; Pharmaceutical Research & Manufacturers Of America Foundation
• Investigators: Principal Investigator: Nino Isakadze, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Mobile Health; Digital Health; Remote Patient Monitoring; Risk Factor Modification
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Behavior
• Other Study ID Numbers: IRB00453569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No